MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK RX CORONARY DILATATION CATHETER

Catalog Number	1012455-20
Medical Device Problem Codes	Failure to Fold (1255); Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: medical device problem code 2017/excessive force; 1494/incorrect anatomy.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a stenosed anastomosis lesion in the left radial artery fistula.The 5.0x20mm nc trek balloon dilatation catheter (bdc) was inflated to nominal and then deflated but the physician did not wait long enough before removing so the balloon was not totally deflated before pulling through the sheath.The physician pulled on the balloon to try to get in through the sheath and snapped the catheter outside the sheath due to force that was applied.The sheath was then pulled out to retrieve the balloon.It was noted that the balloon had bunched up at the distal end preventing it from moving through the sheath.The case was finished when the difficulty in removal occurred.Nothing remains in the patient.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6: correction: medical device problem code 2889 was removed and 1255 was added.A visual inspection was performed on the returned device.The reported separation was confirmed.The reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.The reportable balloon bunching could not be confirmed since the that portion of the device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: withdraw the deflated dilatation catheter and guide wire from the guiding catheter through the hemostatic valve.Additionally, the warning section states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.In this case, it is likely that the balloon being removed not fully deflated resulted in the reported bunching of the balloon, difficulty removing the device and subsequently as force was applied the device ultimately separated.Additionally, it was reported that the procedure was to treat a stenosed anastomosis lesion in the left radial artery fistula.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use (ifu) states: the nc trek rx coronary dilatation catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm ¿ 5.00 mm only).In this case, it is unknown if the ifu violation contributed to the reported complaint because abbott has not evaluated this use.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The investigation determined the reported balloon bunching, difficulty removing the device and separation appear to be related to user error since the physician did not wait long enough for the balloon to deflate before attempting to remove it.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: NC TREK RX CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18508758
• Report Number: 2024168-2024-00766
• Device Sequence Number: 7875713
• Product Code: LOX
• UDI-Device Identifier: 08717648152160
• UDI-Public: (01)08717648152160(17)250430(10)20526G1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: 1012455-20
• Device Lot Number: 20526G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male